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United States · US · US:29300-127_958d523d-b040-4475-ad89-6278e5cf0f60
Bisoprolol Fumarate
Orange BookUNIISPLATC C07AB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeC07AB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112930012701100 TABLET in 1 BOTTLE, PLASTIC (29300-127-01)
- ndc112930012705500 TABLET in 1 BOTTLE, PLASTIC (29300-127-05)
- ndc11293001271330 TABLET in 1 BOTTLE, PLASTIC (29300-127-13)
Annotations
UNII (FDA Substance ID)
UR59KN573L
BISOPROLOL FUMARATE
RxCUI 142146
Orange Book
A078635
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UR59KN573L",
"rxcui": "142146",
"inchikey": "VMDFASMUILANOL-WXXKFALUSA-N",
"display_name": "BISOPROLOL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c3ee566c-74c4-45f4-a947-526a7313e326": {
"match": "brand_token",
"title": "BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED [MICRO LABS LIMITED]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "29300-127_958d523d-b040-4475-ad89-6278e5cf0f60",
"productndc": "29300-127",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078635",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 18, 2009"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 18, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BISOPROLOL FUMARATE",
"proprietary_name": "Bisoprolol Fumarate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078635",
"marketing_category": "ANDA",
"nonproprietary_name": "Bisoprolol fumarate",
"start_marketing_date": "20090921",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AB07.
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